Quality Engineer (Medical Device) | Devens, MA| Onsite

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Stellent IT LLC
Devens, MA, United States
  • Healthcare
  • Applications have closed

Title: Quality Engineer (Medical Device)

Location: Devens, MA| Onsite

Duration: 6-12+ Months

Job Summary

  • A fast-growing manufacturing company is seeking a Process Validation resource to support their expanding operations team. This individual will be responsible for leading and executing activities across manufacturing processes, with a focus on developing and implementing robust validation protocols, conducting PFMEAs, and ensuring test methods are accurate, repeatable, and compliant with industry standards.

Key Responsibilities

  • Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
  • Lead and facilitate Process Failure Modes and Effects Analysis (PFMEA) sessions to identify and mitigate risks.
  • Design and validate test methods to ensure product quality and regulatory compliance.
  • Collaborate with cross-functional teams including Quality, Engineering, and Manufacturing to support continuous improvement initiatives.
  • Analyze data from validation activities and provide recommendations for process optimization.
  • Maintain documentation in accordance with internal procedures and regulatory requirements.
  • Write and maintain detailed work instructions, standard operating procedures (SOPs), and process documentation to ensure repeatable and high-quality production.

Required Qualifications

  • 10 years of experience in process validation.
  • Medical Device experience (not Pharma).
  • Orthopedic experience.
  • Experience with FMEAs.
  • IQ, OQ, PQ experience.

Best regards,

Lavesh Kumar

| Sr. Technical Recruiter

STELLENT IT A Nationally Recognized Minority
Certified Enterprise

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